Author: Timothy Snow, DO
Boston Scientific Neuromodulation Corporation received FDA approval for the Precision Spinal Cord Stimulation (SCS) System on August 11, 2017.
The Boston Scientific Spinal Cord Stimulation system is an implantable device used as an adjunct in the management of chronic intractable pain related to the trunk and/or limbs. This device is the first FDA approved device that offers a combination of both paresthesia-based and sub-perception therapy to assist in the control of chronic pain.
An implanted pulse generator is inserted through a small incision in the patient’s back and delivers electrical signals to the dorsal column of the spinal cord through an insulated wire. These signals vary in amplitude, frequency, and pulse width, and are intended to interrupt pain signals. The patient is able to control this stimulator device through a handheld remote to achieve adequate pain control, allowing for real-time feedback and enhanced customization of overall pain management. Prior to implantation, the patient will undergo a trial period with an external stimulator to determine if treatment with the implantable pulse generator will provide an adequate pain response.
A literature review of 22 published clinical studies representing 644 SCS patients demonstrated an improvement in pain ranging from 29.2%-100% for CRPS patients, and 37-77% for those with back and leg pain due to surgery-associated etiologies. A complication rate of 22.24% was observed, with lead migration and malfunction being the most commonly identified at 16%. The WHSIPER SCS Study also demonstrated that patients have more favorable pain outcomes when using a SCS that utilizes both paresthesia and sub-perception based therapy.
The Boston Scientific SCS System is similar to other SCS systems reported in the published literature for similar intended use, target patient population, device design, and output characteristics. Other treatments for this type of chronic intractable pain typically consists of less invasive therapies. These include oral medications, massage therapy, Physical/Occupational/Exercise Therapy, Psychological Therapy, Transcutaneous Electrical Nerve Stimulation (TENS), Acupuncture, and Nerve/Joint Blocks. Other surgical therapies include Sympathectomy, Implantable intrathecal drug delivery systems, and partially implanted SCS devices.
Chronic Intractable Pain (Unilateral or Bilateral) and Radiculopathies of the Trunk or Limbs due to the following:
Complex Regional Pain Syndrome (CRPS) Type I and II
Failed Back Surgery Syndrome
Radicular Pain Syndrome
Degenerative Disc Disease (DDD)
Patients with ineffective relief of pain during trial period
Patient incapable of managing his or her remote control for the stimulation device
Patient unable to safely tolerate surgery